Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia; Ophthalmology Division, Department of Surgery, The University of Melbourne, Melbourne, Australia.
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia; Ophthalmology Division, Department of Surgery, The University of Melbourne, Melbourne, Australia.
Ophthalmol Retina. 2020 Jun;4(6):568-575. doi: 10.1016/j.oret.2019.12.011. Epub 2019 Dec 16.
Nascent geographic atrophy (nGA) describes features on OCT imaging previously observed to precede the development of atrophy. This study sought to prospectively evaluate the predictive ability of nGA for the conventional clinical endpoint of geographic atrophy (GA) as defined on color fundus photography (CFP).
Prospective, longitudinal, observational study.
A total of 284 eyes from 142 participants with bilateral large drusen and without nGA nor late age-related macular degeneration (AMD) at baseline were included.
OCT volume scans and CFP images were obtained from all participants at baseline and then at 6-month intervals for up to 36 months. OCT and CFP images were graded independently for the presence of nGA and GA, respectively. Eyes that developed neovascular AMD were censored at the day of its detection.
Time to development of GA.
A total 12 eyes from 10 participants progressed to GA over 36 months of follow-up, and nGA was detected in 10 of these eyes (83%) at a preceding visit (median, 13 months prior; interquartile range, 6-25 months). A total of 40 eyes from 28 participants developed nGA or GA over 36 months of follow-up, and the probability of progression to nGA and GA after 36 months was 20% (95% confidence interval [CI], 14%-28%) and 9% (95% CI, 6%-13%), respectively. After the detection of nGA, the probability of progression to GA was 38% (95% CI, 15%-55%) after 24 months. The development of nGA was associated with a markedly increased risk of progression to GA compared with when it did not develop (adjusted hazard ratio, 78.1; 95% CI, 13.6-448.0; P < 0.001), and the development of nGA explained 91% of the variance in the time to GA development.
This study prospectively demonstrated that nGA was a strong predictor for the development of GA, providing supportive evidence of the potential value of nGA as a surrogate endpoint in future intervention trials for the early stages of AMD to improve their feasibility substantially.
新生性地图状萎缩（nGA）描述了 OCT 成像上先前观察到的在萎缩发展之前的特征。本研究旨在前瞻性评估 nGA 对传统临床终点（定义为眼底彩色照相法（CFP）中的地图状萎缩（GA））的预测能力。
前瞻性、纵向、观察性研究。
共纳入 142 名参与者的 284 只双眼，这些参与者双眼均有大量玻璃膜疣，但基线时无 nGA 或晚期年龄相关性黄斑变性（AMD）。
所有参与者在基线时接受 OCT 容积扫描和 CFP 图像检查，然后每隔 6 个月进行一次检查，最长可达 36 个月。OCT 和 CFP 图像分别独立分级，以确定是否存在 nGA 和 GA。出现新生血管性 AMD 的眼在其检测日被截尾。
GA 发展时间。
在 36 个月的随访中，共有 12 只眼（10 名参与者）进展为 GA，其中 10 只眼（83%）在之前的就诊中发现了 nGA（中位数，13 个月前；四分位间距，6-25 个月）。在 36 个月的随访中，共有 40 只眼（28 名参与者）出现 nGA 或 GA，36 个月后进展为 nGA 和 GA 的概率分别为 20%（95%置信区间[CI]，14%-28%）和 9%（95% CI，6%-13%）。在发现 nGA 后，24 个月时进展为 GA 的概率为 38%（95% CI，15%-55%）。与未发生 nGA 相比，发生 nGA 与进展为 GA 的风险显著增加（调整后的危险比，78.1；95% CI，13.6-448.0；P<0.001），nGA 的发生解释了 GA 发展时间的 91%的方差。
本研究前瞻性地证明，nGA 是 GA 发展的一个强有力预测因子，为 nGA 作为 AMD 早期阶段干预试验中的替代终点提供了支持性证据，这将大大提高这些试验的可行性。
